Maintaining CE Compliance in Serial Production: Key Quality Control Steps

Production Controls in the CE Compliance Process – How to Maintain Consistency in Mass Production?

The CE mark not only applies to the initial product but also signifies that all production batches fully comply with the applicable conformity requirements. Therefore, it is mandatory to keep production processes under control even after obtaining the CE certificate.

So, how can you maintain CE compliance during mass production? In this article, we examine how production control is maintained for CE-marked products, the risks encountered, and the technical support offered by SERTİFİKE.

Is Obtaining a CE Certificate Sufficient?

No.
The CE mark is not only a one-time indication of conformity-it must be ensured continuously across all products. Manufacturers are therefore responsible for implementing quality control and monitoring systems throughout serial production.

What is Factory Production Control (FPC)?

FPC is a quality management system designed to guarantee that products are manufactured to the same standard during mass production. For many product groups under EU legislation, this system is mandatory.

Core Components of an FPC System:

Raw material control procedures
Traceability throughout production steps
Testing at critical control points
Final product inspection checklists
Record-keeping and monitoring procedures

For example, FPC is indispensable in CE marking for construction materials and pressure equipment.

Which Directives Require Continuous Production Control?

Some CE directives require ongoing oversight beyond the initial product testing phase:

Construction Products Regulation (CPR – 305/2011)
ATEX Directive (2014/34/EU)
Gas Appliances (2016/426)
Pressure Equipment Directive (PED – 2014/68/EU)
Medical Devices Regulation (MDR – 2017/745)

These regulations demand that the manufacturer continually demonstrate control over the technical file and the product throughout its lifecycle.

Common Mistakes in Serial Production

Typical errors that can result in the loss of CE compliance during mass production include:

Relying solely on initial conformity testing and failing to monitor ongoing production
Skipping inspection of components from different suppliers
Affixing the CE mark on the final product without updating the technical file
Not keeping up with updates in testing standards

Such issues increase the risk of product recalls and can damage the brand’s reputation.

Conclusion

The CE mark is essential for ensuring that your product can circulate freely in the European market. However, this conformity is not a one-time achievement. Maintaining quality and compliance during mass production is a fundamental part of the CE system.

At SERTİFİKE, we support you in sustaining your technical competence throughout production-ensuring your product continuously meets market expectations with confidence and consistency.

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